BEUDAMED
    FDA Adverse Event Other Summary report: N

    VIASYS

    MDR report key: 3012069 · Received March 7, 2013

    Report

    Report Number
    2021710-2013-00012
    Event Type
    Other
    Date Received
    March 7, 2013
    Date of Event
    February 6, 2013
    Manufacturer
    CAREFUSION
    Product Code
    CBK
    PMA / PMN Number
    K073069
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    CAREFUSION SENT A LETTER VIA EMAIL TO THE USER FACILITY SEEKING ADDITIONAL INFORMATION CONCERNING THE REPORTED EVENT AND THE CONDITION OF THE PATIENT. AS OF (B)(4) 2013 THERE HAS BEEN NO RESPONSE TO THE LETTER FROM THE USER FACILITY. THE USER FACILITY DID NOT SUBMIT A USER FACILITY REPORT TO THE MANUFACTURER. EVENT CODES WERE DERIVED BASED ON INFORMATION DOCUMENTED BY A CAREFUSION TECH SUPPORT SPECIALIST IN RESPONSE TO A PHONE CONVERSATION(S) WITH A USER FACILITY REPRESENTATIVE. (B)(4). THE FOLLOWING INFORMATION CONCERNING THE EVALUATION OF THE DEVICE IS A SUMMARY OF THE INFORMATION DOCUMENTED BY THE CAREFUSION FACTORY SERVICE REPRESENTATIVE AND THE CAREFUSION FAILURE ANALYSIS LAB TECH. THE CAREFUSION FACTORY SERVICE DEPARTMENT REPRESENTATIVE IN CONJUNCTION WITH THE FAILURE ANALYSIS LAB TECH EVALUATED THE UNIT AND WERE NOT ABLE REPRODUCE OR VERIFY THE REPORTED FAILURE THUS WE WERE NOT ABLE TO IDENTIFY A ROOT CAUSE IN THIS ALLEGED EVENT. THE CAREFUSION FACTORY SERVICE REPRESENTATIVE RAN THE UNIT THROUGH A COMPLETE CHECKOUT TO ENSURE IT MEETS ALL FACTORY SPECIFICATIONS. UPON COMPLETION THE UNIT WAS RETURNED TO THE CUSTOMER READY TO BE PLACED BACK INTO SERVICE.

    Description of Event or Problem · 1

    THE FOLLOWING DESCRIPTION OF THE EVENT WAS DOCUMENTED BY AS CAREFUSION TECH SUPPORT SPECIALIST IN RESPONSE TO A PHONE CONVERSATION WITH USER FACILITY REPRESENTATIVE(S). "WHEN RT ENTERED THE ROOM THE PT WAS BEING BAGGED, DECREASED SPO2, FROZEN SCREEN, PT WAS STABILIZED AND RT ((B)(6)) RECONNECTED THE VENT BUT IT DID NOT VENTILATE SO VENT WAS REMOVED FROM PT. NO HARM TO THE PT."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    98442 VIASYS VENTILATOR, CONTINUOUS, FACILITY USE/CBK CBK CAREFUSION AVEA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Other ASKU